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The purpose of this study is to evaluate if the meal marker and reminder feature of the Contour meter along with education maintains or increases frequency of testing blood sugar after meals and enables behavioral changes that may lead to improvement in glycemic control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Level1 Basic Meter Features | Experimental | Adults with type 1 and type 2 diabetes use only basic features (Level 1) to test their blood. The CONTOUR meter has the basic features such as small meter size, easy to use , No Coding™ technology, 5-second test time, small sample size (0.6 µL), automatic control solution marking, 480 reading memory capacity. |
|
| Level 2 Advanced Meter Features | Experimental | Adults with type 1 and type 2 diabetes additionally access and use more advanced meter features(Level 2)during blood glucose testing. The advanced features include ability to mark blood glucose values as obtained before or after meals or to set an audible reminder to test. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education + new meter | Device | Diabetes education and a new meter with basic features |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Level 2 Participants Who Rated Helpfulness of Advanced Meter Features as 1 or 2 | Level 2 participants, who used advanced meter features, responded to questionnaires. They rated helpfulness of the meal marker reminder feature on a 5 point scale, 1 being strongly agree and 5 being strongly disagree. | Over six month period |
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Inclusion Criteria:
Persons with type 1 or type 2 diabetes
Persons who are on a pump or are taking at least 1 mealtime injection of insulin a day
Persons at least 21 years of age
Persons willing to complete all study visits and study procedures including:
Testing their BG at least 3 times a day during the entire study.
Persons who are able to speak, read and understand English
Persons who are currently performing self-testing of blood glucose at home routinely (at least 3 times per day) for 4 weeks or more
Exclusion Criteria:
Persons who have been using a CONTOUR, BREEZE or BREEZE 2 meter regularly during the previous 6 months
Persons who test over 6 times/day regularly
Persons who wear a BG sensor 2 weeks or more during each month.
Persons with home heath aides who assist with their BG testing.
Persons with the following impairments which, in the opinion of the investigator, would seriously compromise the integrity of the study:
Any other condition as per investigator's discretion
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| Name | Affiliation | Role |
|---|---|---|
| Dace Trence, MD | University of Washington Medical Center/Diabetes Care Center | Principal Investigator |
| Bruce W Bode, MD | Atlanta Diabetes Associates | Principal Investigator |
| Ronald Tamler, MD, Phd, MBA | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Richard M Bergenstal, MD | International Diabetes Center at Park Nicollet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta Diabetes Associates | Atlanta | Georgia | 30309 | United States | ||
| International Diabetes Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Level1 Basic Meter Features | Adults with type 1 and type 2 diabetes using basic meter features |
| FG001 | Level 2 Advanced Meter Features | Adults with type 1 and type 2 diabetes using advanced meter features. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Level1 Basic Meter Features | Adults with type 1 and type 2 diabetes using basic meter features |
| BG001 | Level 2 Advanced Meter Features | Adults with type 1 and type 2 diabetes using advanced meter features. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features | For level 1, 14 subjects were lost to follow-up, that is they did not continue through the study's 4 visits, and data was not available. For level 2, 15 subjects were likewise lost to follow-up and data was not available. For units analyzed, 74 and 68 refer to the number of logbooks available. | Posted | Oct 2010 | Mean | Standard Error | number of post-prandial tests per week | 6 months |
|
6 months
All serious adverse events were not linked to the study device.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Level1 Basic Meter Features | Adults with type 1 and type 2 diabetes using basic meter features |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Endocrine disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carmine Greene, Senior Clinical Research Scientist | Ascensia Diabetes Care | 574-257-3040 | carmine.greene@ascensia.com |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Education + new meter + feature activation | Device | Diabetes education and a new meter with advanced features |
|
| Minneapolis |
| Minnesota |
| 55416 |
| United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| University of Washington Medical Center/Diabetes Care Center | Seattle | Washington | 98105 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Secondary | Percent of Level 2 Participants Who Rated Helpfulness of Advanced Meter Features as 1 or 2 | Level 2 participants, who used advanced meter features, responded to questionnaires. They rated helpfulness of the meal marker reminder feature on a 5 point scale, 1 being strongly agree and 5 being strongly disagree. | 63 surveys were available for analysis. | Posted | Oct 2010 | Number | percent of Level 2 participants | Over six month period |
|
|
|
| 12 |
| 106 |
| 0 |
| 94 |
| EG001 | Level 2 Advanced Meter Features | Adults with type 1 and type 2 diabetes using advanced meter features. | 6 | 105 | 0 | 99 |
| Hyperglycemia | Endocrine disorders | Non-systematic Assessment |
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| Heart attack | Cardiac disorders |
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| Trachial infection | Respiratory, thoracic and mediastinal disorders |
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| Adrenal growth | Endocrine disorders |
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| Shortness of breath | Respiratory, thoracic and mediastinal disorders |
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| Diverticulosis | Gastrointestinal disorders |
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| Sepsis | Blood and lymphatic system disorders |
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| Mastectomy | Reproductive system and breast disorders |
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| GI Bleeding | Gastrointestinal disorders |
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| Upper abdominal pain | Gastrointestinal disorders |
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| Hypotensive | Cardiac disorders |
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| Lower leg edema | Blood and lymphatic system disorders |
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| Coronary artery bypass | Cardiac disorders |
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| Eating disorder | Psychiatric disorders |
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| Lymphadema of arm | Blood and lymphatic system disorders |
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